Risedronate Sodium 5 Mg Film-Coated Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Risedronate sodium 5 mg film-coated tablets
risedronate sodium
Read all of this leaflet carefully before you start taking this medicine.
• Keepthisleaflet. You may need to read it again.
• Ifyouhave any questions, ask your doctor or pharmacist.
• Thismedicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• Ifanyofthe side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
The name of your medicine is Risedronate sodium 5 mg film-coated tablets (referred to as Risedronate tablets throughout this leaflet).
1. What Risedronate tablets is and what it is used for
2. Before you take Risedronate tablets
3. How to take Risedronate tablets
4. Possible side effects
5. How to store Risedronate tablets
6. Further information
1. WHAT RISEDRONATE TABLETS IS AND WHAT IT IS USED FOR
What Risedronate tablets is
Risedronate tablets belongs to a group of non-hormonal medicines called bisphosphonates which are used to treat bone diseases. It works directly on your bones to make them stronger and therefore less likely to break.
Bone is a living tissue. Old bone is constantly removed from your skeleton and replaced with new bone.
Postmenopausal osteoporosis is a condition occurring in women after the menopause where the bones become weaker, more fragile and more likely to break after a fall or strain.
Osteoporosis is more likely to occur in women who have reached the menopause early and also in patients treated long-term with steroids.
The spine, hip and wrist are the most likely bones to break, although this can happen to any bone in your body. Osteoporosis related fractures can also cause back pain, height loss and a curved back. Many patients with osteoporosis have no symptoms and you may not even have known that you had it.
What Risedronate tablets is used for
The treatment of osteoporosis
• in postmenopausal women.
The prevention of osteoporosis
• in women with an increased risk of osteoporosis (including low bone mass, early menopause or a family history of osteoporosis).
• in postmenopausal women who have been on high doses of steroid drugs for a long time. It maintains or increases bone mass.
• Ifyouhave had problems in the past with your oesophagus (the tube that connects your mouth with your stomach). For instance you may have had pain or difficulty in swallowing food or you have previously been told that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus).
• Ifyouhave been told by your doctor that you have an intolerance to some sugars (such as lactose).
• Ifyouhave had or have pain, swelling or numbness of the jaw or a “heavy jaw feeling” or loosening of a tooth.
• Ifyouareunder dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Risedronate tablets.
Your doctor will advise you on what to do when taking Risedronate tablets if you have any of the above.
Children and adolescents
Risedronate tablets are not recommended for use in children and adolescents below age 18 due to insufficient data on safety and efficacy.
Taking other medicines
Medicines containing one of the following lessen the effect of Risedronate tablets if taken at the same time:
• calcium
• magnesium
• aluminium (for example some indigestion mixtures)
• iron
Take these medicines at least 30 minutes after your Risedronate tablets.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Risedronate tablets with food and drink
It is very important that you do NOT take your Risedronate tablets with food or drinks (other than plain water) so that it can work properly. In particular do not take this medicine at the same time as dairy products (such as milk) as they contain calcium (see section 2, “Taking other medicines”).
Take food and drinks (other than plain water) at least 30 minutes after your Risedronate tablets.
Pregnancy and breast-feeding
Do NOT take Risedronate tablets if you may be pregnant, are pregnant or planning to become pregnant (see section 2, “Do not take Risedronate tablets”). The potential risk associated with the use of risedronate sodium (active substance in Risedronate tablets) in pregnant women is unknown.
Do NOT take Risedronate tablets if you are breast-feeding (see section 2, “Do not take Risedronate tablets”).
Driving and using machines
Risedronate tablets is not known to affect your ability to drive and use machines.
Important information about some of the ingredients of Risedronate tablets
Risedronate tablets contain a small amount of lactose (see section 2, “Take special care and talk to your doctor before you start taking Risedronate tablets”).
2. BEFORE YOU TAKE RISEDRONATE TABLETS
3. HOW TO TAKE RISEDRONATE TABLETS
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Do NOT take Risedronate tablets
• Ifyouareallergic to risedronate sodium or any of the other ingredients of Risedronate tablets (see section 6, “What Risedronate tablets contains”).
• Ifyourdoctor has told you that you have a condition called hypocalcaemia (a low blood calcium level).
• Ifyoumay be pregnant, are pregnant or planning to become pregnant.
• Ifyouare breast-feeding.
• Ifyouhave severe kidney problems.
Take special care and talk to your doctor BEFORE you start
taking Risedronate tablets
• Ifyouareunable to stay in an upright position (sitting or standing) for at least 30 minutes.
• Ifyouhave abnormal bone and mineral metabolism (for example lack of vitamin D, parathyroid hormone abnormalities, both leading to a low blood calcium level).
Dosage
Always take Risedronate tablets exactly as your doctor has told you. You should check with your doctor if you are not sure.
Usual dose:
Take ONE Risedronate tablets (5 mg of risedronate sodium) once a day.
WHEN to take the Risedronate tablets
IT IS BEST to take your Risedronate tablets at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day.
If in particular instance you are unable to take your Risedronate tablets at this time, you may take it on an empty stomach, at the same time every day, in one of the following ways:
• EITHER
Between meals: at least 2 hours after your last food, drink (other than plain water) or other medicine. Do not eat or drink (other than plain water) for 2 hours after taking the tablet.
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• OR
In the evening: at least 2 hours after your last food, drink (other than plain water) or other medicine of the day. Risedronate tablets should be taken at least 30 minutes before going to bed.
HOW to take the Risedronate tablets
• Takethetablet whilst you are in an upright position (you may sit or stand) to avoid heartburn.
• Swallow it with at least one glass (120 ml) of plain water.
• Swallowit whole. Do not suck or chew it.
• Do notlie down for 30 minutes after taking your tablet.
Your doctor will tell you if you need calcium and vitamin supplements, if you are not taking enough from your diet.
If you take MORE Risedronate tablets than you should
If you or somebody else has accidentally taken more Risedronate tablets than prescribed, drink one full glass of milk and seek medical attention.
If you FORGET to take Risedronate tablets
If you have forgotten to take your tablet at your regular time, you can take it at the next possible time according to the instruction above (i.e. before breakfast, between meals, or in the evening).
Do not take two tablets in one day to make up for the tablet you missed.
If you STOP taking Risedronate tablets
If you stop treatment you may begin to lose bone mass. Please talk to your doctor before you consider stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist
4. POSSIBLE SIDE EFFECTS
Like all medicines, Risedronate tablets can cause side effects, although not everybody gets them.
Stop taking Risedronate tablets and contact a doctor immediately if you experience any of the following:
• Symptoms of a severe allergic reaction such as:
- Swelling of the face, tongue or throat.
- Difficulties in swallowing.
- Hives and difficulties in breathing.
• Severeskin reactions that can include blistering of the skin.
Tell your doctor promptly if you experience the following side effects:
• Eyeinflammation, usually with pain, redness and light sensitivity.
• Bonenecrosis of the jaw (osteonecrosis) associated with delayed healing and infection, often following tooth extraction (see section 2, “Take special care and talk to your doctor before you start taking Risedronate tablets”).
• Symptoms from oesophagus such as pain when you swallow, difficulties in swallowing, chest pain or new/worsened heartburn.
However in clinical studies the other side effects that were observed were usually mild and did not cause the patient to stop taking their tablets.
Common side effects (affects 1 to 10 users in 100)
• Indigestion, feeling sick, stomach ache, stomach cramps or discomfort, constipation, feelings of fullness, bloating, diarrhoea.
• Paininyour bones, muscles or joints.
• Headache.
Uncommon side effects (affects 1 to 10 users in 1,000)
• Inflammation or ulcer of the oesophagus (the tube that connects your mouth with your stomach) causing difficulty and pain in swallowing (see also section 2, “Take special care and talk to your doctor before you start taking Risedronate tablets”), inflammation of the stomach and duodenum (bowel draining the stomach).
• Inflammation of the coloured part of the eye (iris) (red painful eyes with a possible change in vision).
Rare side effects (affects 1 to 10 users in 10,000)
• Inflammation of the tongue (red swollen, possibly painful), narrowing of the oesophagus (the tube that connects your mouth with your stomach).
• Abnormal liver tests have been reported. These can only be diagnosed from a blood test.
During post-marketing experience, the following have been reported (unknown frequency);
• Hairloss.
• Liverdisorders, some cases were severe.
Rarely, at the beginning of treatment, a patient's blood calcium and phosphate levels may fall. These changes are usually small and cause no symptoms.
Unusual fracture of the thigh bone particularly in patients on longterm treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE RISEDRONATE TABLETS
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Risedronate tablets contains
The active substance is risedronate sodium. Each film-coated tablet contains 5 mg risedronate sodium (equivalent to 4.6 mg risedronic acid).
The other ingredients are:
Tablet core: Lactose monohydrate, crospovidone, hydroxy propyl cellulose, magnesium stearate and cellulose microcrystalline.
Film coating: Hypromellose, titanium dioxide (E171), macrogol 400, hydroxy propyl cellulose, iron oxide yellow (E172), macrogol 8000 and silica colloidal Anhydrous.
What Risedronate tablets looks like and contents of the pack
Film-coated tablet.
Yellow coloured, circular shaped, beveled edge, film-coated biconvex tablets debossed with 'X' on one side and '61' on the other side.
Transparent PVC / PE / PVdC / Aluminium blisters in a cardboard box, Packs 14, 20, 28, 84, 98 or 140 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta
This medicinal product is authorised in the Member States of the EEA under the following names:
RISEDRONATE AUROBINDO 5 mg comprime pellicule
Risedronat Aurobindo 5 mg Filmtabletten Risedronate Aurobindo 5 mg film-coated tablets Risedronato Aurobindo 5 mg compresse rivestite con film
Risedronate Aurobindo 5 mg film-coated tablets Risedronat Aurobindo 5 mg comprimidos recubiertos con pelfcula
Natriumrisedronaat Aurobindo 5 mg, filmomhulde tabletten
Risedronate sodium 5 mg film-coated tablets
This leaflet was last approved in 09/2013.
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